Kornimate/medical-research-clean huggingface dataset:
evaluation of a modern system to allow for growth in children with scoliosis versus a conventional treatment

Conditions: Early Onset Scoliosis

Summary: the foremost challenge when managing early onset scoliosis (curve deformity before the age of 10) is to prevent curve progression while maintaining growth of the spine. current treatment options require repetitive interventions as the spine and the child grow. this study will compare two techniques of growth modulation: standard dual growing rods versus the new luqué trolley screws hypothesis: patients treated with the depuy synthes trolley system will undergo fewer re-operations after 3 years of follow-up (fu) than patients included in the comparison group

the purpose of this clinical study is to show that the growth guiding construct with depuy synthes trolley gliding vehicles allows for less re-operations and for ongoing spinal growth across an instrumented immature spine while preventing curve progression in early onset scoliosis patients.

Eligibility criteria:
inclusion criteria: * age 5 - 10 years * diagnosis of early onset scoliosis with any of the following etiologies: idiopathic congenital neuromuscular syndromic mesenchymal - significant growth potential defined by any of the following: pre peek growth velocity bone age \< 10; open triradiate cartilage * an expected significant spinal deformity of more than 80 degrees at skeletal maturity * signed informed consent as legally required (patient, parents, etc.) * willingness and ability of the patient to participate in the clinical investigation including imaging and fu procedures * willingness and ability of the parents to support the patient in his/her study participation * ability of the patient and parents to understand the content of the patient information / informed consent form and participate in the clinical investigation * signed informed consent by patient / parent(s) exclusion criteria: * curve magnitude and rigidity: cobb greater than 100 degrees or bends less than 50 degrees * prior spinal surgery * skeletal maturity * any not medically managed severe systemic disease * participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Keywords: scoliosis [mesh] pediatrics [mesh] early onset growth guidance growing rod trolley dual growing rod technique
the longitudinal pth-study

Conditions: CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder; Secondary Hyperparathyroidism; Kidney Replacement

Summary: the main study aim is to quantify the agreement between the analytical results provided by two third generation and two second generation parathyroid hormone (pth) assays. the primary comparison will be performed between the second-generation pth assay"intact pth assay" from siemens healthcare diagnostics inc. and the third-generation pth assay "biointact (1-84)" from roche diagnostics in terms of a bland-altman analysis. several studies have evaluated the correlation between various pth assays at a single time-point, but no previous study has tested the hypothesis that longitudinal changes in pth levels, which are important for making treatment decisions, can be monitored by several pth assays alike. to this aim, the key secondary objective is to analyze the longitudinal variance in pth over the course of 1 year, using each of two assays of the second and third generations, respectively. other secondary objectives include determining changes in serum phosphate, serum calcium, fibroblast growth factor 23 (fgf23), with respect to treatment decisions. for clinical applicability of the results to be obtained here, an important goal of the present study will be not to influence treatment decisions, which will remain independent of the study investigators, at the full responsibility of the hemodialysis physicians. at every quarterly blood draw over the course of one year, the investigators will freeze the serum from 100 patients, and at the end of 4 quarters the investigators will analyze pth-levels using the following assays: intact parathyroid hormone (advia centaur, siemens healthcare), pth-intact (cobas, roche), pth (1-84) - the agreement between the pth assays will be analyzed at baseline, as well as at the subsequent quarterly evaluation time-points by bland-altman analysis and complemented by passing-bablok regression. the longitudinal changes in pth will be displayed graphically and analyzed by estimating the within-patient variance across time, the between patient variance at each time-point as well as effects on the mean log-pth level due to course of disease and therapeutic interventions from a linear mixed model.


Eligibility criteria:
inclusion criteria: * all patients who were undergoing uninterrupted hemodialysis or hemodiafiltration at the chronic hemodialysis unit of the division of nephrology and dialysis, medical university of vienna between november 1st, 2017 and december 31st, 2018. * existence of residual blood samples from four successive quarterly routine controls * age ≥ 18 years * the test result of the assay must not have any diagnostic value or therapeutic consequence for the patients included in this study. exclusion criteria: * death during the observational period (all patients must have lived through the 1-year period and must have all 4 quarterly blood draws performed on them). * age \<18 years
main postoperative complications after covid-19

Conditions: Intestines Cancer; Pulmonary Cancer; Liver Cancer; Trauma; Fractures, Bone

Summary: to explore the relationship between sars-cov-2 infection in different time before operation and postoperative main complications (mortality, main pulmonary and cardiovascular complications) 30 days after operation; to determine the best timing of surgery after sars-cov-2 infection.


Eligibility criteria:
inclusion criteria: * age≥18 years; * patients undergoing any type of elective or confine surgery in operating room; * informed consent. exclusion criteria: * surgery under local anesthesia (without participation of anesthetist) * surgery outside the operating room, such as gastrointestinal endoscopy, puncture biopsy, etc * patients who cannot determine whether they have had sars cov-2 infection before surgery * participating in conflicting clinical study
study with cabazitaxel in previously treated patients with advanced or metastatic gastric cancer

Conditions: Gastric Cancer

Summary: single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment.

65 patients with advanced or metastatic adenocarcinoma of the oesophagogastric junction and stomach will be treated with 20mg/m2 cabazitaxel for a maximum of 6 cycles. main objective of the study is the disease control rate (dcr) with cabazitaxel.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach 2. progression of a measurable lesion (recist) on previous palliative chemotherapy. neoadjuvant/adjuvant treatment is not counted, unless progression occurs \< 6 months after completion of the treatment. in these cases, neoadjuvant/adjuvant treatment is counted as one line. 3. male and female patients aged \> 18 years 4. ecog ≤ 1 5. neutrophils ≥ 1500/µl 6. haemoglobin ≥ 9 g/dl 7. platelets ≥ 100,000/µl 8. ast/sgot and/or alt/sgpt ≤2.5 x uln; 9. total bilirubin ≤1.0 x uln 10. serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min 11. written patient informed consent exclusion criteria: 1. a history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3) 2. active cad, cardiomyopathy or nyha stage iii-iv heart failure 3. malignant secondary disease dating back \< 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin) 4. severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection 5. concomitant medication or planned treatment with strong cyp450 3a4/5 inducers or inhibitors (list of medicinal products in the appendix) or the relevant medicinal products were not discontinued a minimum of one week before treatment 6. peripheral polyneuropathy \> nci grade ii 7. severe hepatic impairment (ast/alt \> 2.5 x uln, , bilirubin \> 1 x uln) 8. chronic inflammatory bowel disease 9. participation in another study 10. pregnancy or lactation

Keywords: gastric cancer second-line treatment cabazitaxel response
effect of real time continuous glucose monitoring system on the management of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine whether the guardian continuous glucose monitoring system in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes

in diabetes management, compliance, disease awareness and empowerment of the patient play an important role and the immediate feedback on the effects of diet and exercise that the self monitoring blood glucose (smbg) may provide, could enhance patient empowerment. increased use of smbg has been shown to be associated with improved medication compliance and better metabolic control by several studies. however, because of many factors, including pain and inconvenience, many diabetic patients do not accept frequent fingersticks for self blood glucose monitoring (sbgm) levels. in addition, the sbgm result gives the data for only a few seconds, without any information on glucose trends. so we need new glucose monitoring method that could reflect glucose trends and glycemic excursion continuously because glucose monitoring still remains the cornerstone of evaluating the efficacy of therapy and motivating self disease control in subjects with diabetes. few studies have examined the effects of real time continuous glucose monitoring system targeting type 2 diabetes. so our goal is to determine whether the guardian continuous glucose monitoring system in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes

Eligibility criteria:
inclusion criteria: * type 2 diabetes * group 1: hba1c \< 8% with a stable insulin or oral hypoglycemic agents (oha) regimen for the prior 2 months with no plans to switch modality of insulin or oha administration during the next 3months. * group 2: hba1c \>= 8% and the fasting blood glucose must be \< 130 at the same time with a stable insulin or oral hypoglycemic agents (oha) regimen for the prior 2 months with no plans to switch modality of insulin or oha administration during the next 3months exclusion criteria: * use of corticosteroids or hormone therapy within the last 6 months * presence of another chronic illness

Keywords: glucose monitoring system life style intervention
prospective randomized trial about thd versus ligasure hemorrhoidectomy for grade iii and iv hemorrhoids

Conditions: Hemorrhoids

Summary: the study evaluates postoperative pain, morbidity, recurrence and quality of life, comparing two different strategies in the treatment of grade iii and iv hemorrhoids: transanal hemorrhoidal dearterialization with mucopexy (thd) versus hemorrhoidectomy by ligasure™.

transanal hemorrhoidal dearterialization (thd)‪ uses a specially developed anoscope combined with a doppler transducer to identify the hemorrhoidal arteries. a suture ligation is performed to effectively decrease the blood flow to the hemorrhoidal plexus. in case of redundant prolapse, the prolapsed mucosa is lifted (mucopexy). thd procedure is performed without any incisions or removal of the hemorrhoidal tissue and moreover the suture line is above the dentate line, so post-operative pain and morbidities seem to be minimized in these patients. this technique differs from ligasure hemorrhoidectomy, which focuses on excising the hemorrhoidal tissue. this prospective, randomized, multicenter and controlled trial compares post-operative pain, morbidities, quality of life, fecal incontinence and recurrence rate in patients treated for grade iii and iv hemorrhoids with thd with mucopexy versus ligasure hemorrhoidectomy.

Eligibility criteria:
inclusion criteria: * patients with grade iii and iv hemorrhoids according to goligher classification * patients asa i, ii or iii and adequate hematological, renal and hepatic function * patients who signed informed consent exclusion criteria: * altered cognitive state that prevents collaboration in the study or patients who can neither read nor write * fecal incontinence * anal sphincter lesions * recurrent hemorrhoids after previous surgical tratment * previous anorectal surgery except banding, botulinum toxin injection and thrombectomy for hemorrhoid thrombosis * injection sclerotherapy during the last five years * concomitant anorectal disease (anal fistula, anal fissure, anal stenosis, rectocele, enterocele, anal condilomatosis). * concomitant diagnosis of functional pelvic floor disease, inflammatory bowel disease and previous pelvic radiotherapy * concomitant diagnosis of colorectal neoplasia or other neoplasia * patients asa iv, v * nsaids, paracetamol, tramadol, metamizol and petidine allergy * coagulation disorders * pregnancy and lactation * rejection of the patient to sign the consent form.

Keywords: hemorrhoids grade iii and iv transanal hemorrhoidal dearterialization hemorroidectomy thd ligasure
diabetes homelessness medication support program in spanish

Conditions: Diabetes Mellitus, Type 2

Summary: this single-arm trial of the diabetes homeless medication support intervention for spanish-speaking people (n=12) will test the perception and feasibility of anticipated study procedures.

this study has an overall goal to modify and pilot test a previously developed collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and diabetes (dh). the intervention was developed in english. this study is intended to test the modified intervention for dh who speak spanish (dh-sh). the study team's central hypothesis is that medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) will improve with an intervention tailored to the unique context of dh-sh. this protocol tests patient perceptions of the feasibility and acceptability of study procedures and refines the d-homes treatment manual through test cases (n=12). the study team hypothesizes that the d-homes manual and study procedures will be feasible and acceptable to dh-sh as measured by self-report and post-treatment interview.

Eligibility criteria:
inclusion criteria: * age 18 yrs or older * spanish-speaking * recent homelessness by federal definition (hearth act) 1. any housing instability in the last 12 mo. (includes supported housing or worry about paying rent) 2. significant housing instability in the last 24 mos. (includes any stay in shelter, outside, or places not meant for human habitation) * self-reported diagnosis of type 2 diabetes, later verified in medical record * plan to stay in local area or be reachable by phone for the next 16 weeks * willingness to work on medication adherence and diabetes self-care exclusion criteria: * inability to provide informed consent (e.g. presence of a legal guardian, prisoners) * active psychosis or intoxication precluding ability to give informed consent * pregnant or lactating females * patients who choose to opt out of research

Keywords: unstably housed persons hispanic or latino homelessness
perioperative treatment of combined radiotherapy with sox, apatinib and camrelizumab for oesophagogastric cancer

Conditions: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Summary: the study is being conducted to evaluate the efficacy, safety and tolerability of radiotherapy and chemotherapy, apatinib with camrelizumab in the neoadjuvant (prior to surgery) and adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (gej) adenocarcinoma.


Eligibility criteria:
inclusion criteria: * has previously untreated localized gastric or gej adenocarcinoma as defined by t3-4n+m0; * plans to proceed to surgery following pre-operative chemotherapy. has an eastern cooperative oncology group (ecog) performance status score of 0 to 1. * has adequate organ function. * male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy. * female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy. * has life expectancy of greater than 12 months. exclusion criteria: * uncontrolled hypertension ( systolic ≥140 mmhg or diastolic ≥90 mmhg despite antihypertensive therapy) * known hypersensitivity to any of the study drugs or excipients. * known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); * congenital or acquired immune deficiency (e.g. hiv infected)
a virtual reality study of cognitive biases in body dysmorphic disorder

Conditions: Body Dysmorphic Disorders; Healthy

Summary: previous research shows that individuals with body dysmorphic disorder (bdd) misinterpret ambiguous social information in a negative and threatening manner. these erroneous threat appraisals are thought to maintain disorder symptomatology and psychosocial impairment by reinforcing individuals' distorted self-image and ideas of social undesirability. thus, maladaptive interpretation biases represent an important treatment target for this population; however, existing bias assessments and modification protocols are limited by the hypothetical and distal nature of scenarios and do not capture momentary experiential threat processes. the proposed study seeks to test virtual reality (vr) technology as a novel, in vivo means of eliciting, identifying, and measuring threat interpretation biases in a clinical sample to better understand the fear/threat structure activated during social interactions in bdd. findings have the potential to enhance our understanding of disorder maintenance and identify more nuanced treatment targets. this study represents a critical first step in the long-term goal of harnessing vr gaming technology to supercharge existing treatment approaches for this debilitating illness.


Eligibility criteria:
inclusion criteria: * age 18+, * fluent in english, * meet dsm-5 criteria for principal bdd (bdd group) or no other current psychiatric diagnosis (hc group; assessed via clinical interview). exclusion criteria: * lifetime psychosis; current bipolar disorder in acute or hypomanic episode; current severe substance use disorder; acute, active suicidal ideation * intellectual disability or cognitive impairment that would interfere with participation
safety and efficacy of mcc-257 in the treatment of diabetic polyneuropathy

Conditions: Diabetic Polyneuropathy

Summary: the primary objectives of the study are to evaluate the efficacy and safety of three doses of mcc-257 in patients with mild to moderate diabetic polyneuropathy

the study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. patients will be randomized equally to 1 of 4 treatment groups: mcc-257 20 mg, mcc-257 40 mg, mcc-257 80 mg, or placebo, given once daily for 24 weeks. the study will consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a formal screening visit; and 2) a 24-week treatment period, during which patients will take the study treatment, and have various assessments performed during 4 visits.

Eligibility criteria:
inclusion criteria: * the patient is male or female, 18-70 years of age * the patient has either type 1 or type 2 diabetes * the patient has mild to moderate diabetic neuropathy * the patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests exclusion criteria: * being treated with anticoagulants other than aspirin, such as warfarin, digoxin, plavix * bmi\>40 * a significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition * any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function * women of childbearing potential who do not refrain from sexual activity or use adequate contraception * pregnant or lactating women * an alt or ast value \>2x upper limit of normal (uln) * clinically significant cardiovascular disease within the last six (6) months

Keywords: neuropathy nerve conduction
dezoxide suppresses sufentanil-induced cough

Conditions: Sufentanil-induced Cough

Summary: dizocine (0.03 mg/kg) or saline followed by sufentanil 0.4ug/kg was administered, and induction was completed with 3 min of observation. heart rate and mean arterial pressure (map) were recorded before induction of anesthesia, before and 1 min after intubation, and side effects during induction, such as vomiting, hypoxemia (spo2 \<90%), or other expected effects. the number of coughs was recorded in both groups, and the severity of cough was defined as follows: mild, 1-2 coughs; moderate, 3-4 coughs; severe, 5 or more coughs.


Eligibility criteria:
inclusion criteria: * patients admitted for elective valve surgery, artificial vessel replacement or coronary artery bypass graft surgery; age 18\~80 years old; sex is not limited; asa class ii\~iii; nyha class ii-iii; patients or their family members have signed the clinical trial informed consent form exclusion criteria: * upper respiratory tract infection within the last two weeks; long history of smoking; chronic obstructive pulmonary disease; highly reactive airway diseases such as bronchitis and asthma; presence of high cranial pressure, high eye pressure, pulmonary alveolus; malignant tumor, hematological disease, severe liver and kidney dysfunction, recent serious infection, etc.